Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
NCT ID: NCT03673449
Last Updated: 2020-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4 participants
INTERVENTIONAL
2019-03-22
2021-03-31
Brief Summary
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Detailed Description
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SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.
SilkBridge will provide surgeons with an implant with unique features, such as easy suturability, full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue.
The study will have a 12 months and 1 week duration per patient, including the follow-up period, and with an expected enrollment period of 15 months.
The study will evaluate 15 adult patients, aged 18-65 years, diagnosed with digital nerve defects (\> 5 mm gap) in whom surgical repair may not allow direct suture.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SilkBridge treatment
Surgery for digital nerve reconstruction with SilkBridge
SilkBridge
SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.
Interventions
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SilkBridge
SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.
Eligibility Criteria
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Inclusion Criteria
* a traumatic injury or a post-traumatic neuroma of a digital nerve on the palmar side of the hand, between the metacarpophalangeal joint and the distal interphalangeal joint
* single lesion per finger
* nerve defect of \>5mm
* nerve treatment initiated within 24 months after nerve injury
* signed informed consent
Exclusion Criteria
* an additional injury that could compromise nerve regeneration
* clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, metabolic, hematologic, autoimmune, or any systemic disease, which may make implementation/interpretation of the protocol or results difficult
* previous conditions of the hand that could affect the healing of the actual nerve injury
* complete amputation injury
* extensive crush injury
* grossly contaminated wound
* receiving immunosuppressive or antineoplastic agents within 30 days prior to the enrolment
* known to be HIV positive
* known pregnant and lactating females
* participated in another clinical investigation using an investigational new drug or device (or in the present study) within 30 days prior to enrolment into this investigation
* uncooperative or unsuitable, e.g. language problems or a suspicion to be unable to attend follow up appointments, for completion of the investigation
* absence of a healthy opposite finger
* suspected allergy to silk
* need of emergency surgery (within 24 hours from injury)
18 Years
65 Years
ALL
No
Sponsors
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Silk Biomaterials srl
INDUSTRY
Responsible Party
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Principal Investigators
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Maurizio Calcagni, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich
Locations
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Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich
Zurich, , Switzerland
Countries
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References
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Faroni A, Mobasseri SA, Kingham PJ, Reid AJ. Peripheral nerve regeneration: experimental strategies and future perspectives. Adv Drug Deliv Rev. 2015 Mar;82-83:160-7. doi: 10.1016/j.addr.2014.11.010. Epub 2014 Nov 14.
Konofaos P, Ver Halen JP. Nerve repair by means of tubulization: past, present, future. J Reconstr Microsurg. 2013 Mar;29(3):149-64. doi: 10.1055/s-0032-1333316. Epub 2013 Jan 9.
Wieringa PA, Goncalves de Pinho AR, Micera S, van Wezel RJA, Moroni L. Biomimetic Architectures for Peripheral Nerve Repair: A Review of Biofabrication Strategies. Adv Healthc Mater. 2018 Apr;7(8):e1701164. doi: 10.1002/adhm.201701164. Epub 2018 Jan 19.
Ichihara S, Inada Y, Nakamura T. Artificial nerve tubes and their application for repair of peripheral nerve injury: an update of current concepts. Injury. 2008 Oct;39 Suppl 4:29-39. doi: 10.1016/j.injury.2008.08.029.
Pfister LA, Papaloizos M, Merkle HP, Gander B. Nerve conduits and growth factor delivery in peripheral nerve repair. J Peripher Nerv Syst. 2007 Jun;12(2):65-82. doi: 10.1111/j.1529-8027.2007.00125.x.
Daly W, Yao L, Zeugolis D, Windebank A, Pandit A. A biomaterials approach to peripheral nerve regeneration: bridging the peripheral nerve gap and enhancing functional recovery. J R Soc Interface. 2012 Feb 7;9(67):202-21. doi: 10.1098/rsif.2011.0438. Epub 2011 Nov 16.
Meek MF, Varejao AS, Geuna S. Use of skeletal muscle tissue in peripheral nerve repair: review of the literature. Tissue Eng. 2004 Jul-Aug;10(7-8):1027-36. doi: 10.1089/ten.2004.10.1027.
Vepari C, Kaplan DL. Silk as a Biomaterial. Prog Polym Sci. 2007;32(8-9):991-1007. doi: 10.1016/j.progpolymsci.2007.05.013.
Thurber AE, Omenetto FG, Kaplan DL. In vivo bioresponses to silk proteins. Biomaterials. 2015 Dec;71:145-157. doi: 10.1016/j.biomaterials.2015.08.039. Epub 2015 Aug 20.
De Vita R, Buccheri EM, Pozzi M, Zoccali G. Direct to implant breast reconstruction by using SERI, preliminary report. J Exp Clin Cancer Res. 2014 Nov 25;33(1):78. doi: 10.1186/s13046-014-0078-5.
Lee JH, Lee JS, Kim DK, Park CH, Lee HR. Clinical outcomes of silk patch in acute tympanic membrane perforation. Clin Exp Otorhinolaryngol. 2015 Jun;8(2):117-22. doi: 10.3342/ceo.2015.8.2.117. Epub 2015 May 13.
Other Identifiers
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SB_DND-01/2018
Identifier Type: -
Identifier Source: org_study_id
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